Core Viewpoint - The article discusses the rise of monoclonal antibody (mAb) injections, also known as "biological agents," in the treatment of chronic diseases, highlighting the issues surrounding their online sale and the importance of proper medical supervision for their use [1][11]. Group 1: Market Trends - Monoclonal antibodies are becoming mainstream treatments for chronic diseases such as autoimmune disorders and skin diseases due to the expansion of indications and domestic production [1][11]. - The demand for effective treatments in rheumatology and dermatology is increasing, with mAbs being recognized for their significant therapeutic effects [11][12]. Group 2: Online Sales and Regulations - Some pharmaceutical e-commerce platforms are attempting to sell injectable mAbs online, despite regulations prohibiting the online retail of such prescription drugs [2][6]. - Many sellers use terms like "appointment for medication" and "contact customer service after payment" to imply that they are not directly selling the drugs online, which raises compliance concerns [3][6]. Group 3: Safety and Usage - The use of biological agents requires strict adherence to indications and contraindications, necessitating a doctor's assessment and prescription before use [1][5][8]. - Proper cold chain logistics are essential for the safe transport of these drugs, but safety also depends on medical supervision and monitoring during treatment [8][10]. Group 4: Efficacy and Limitations - Biological agents have shown remarkable efficacy in treating various autoimmune diseases, but they are not a cure and require ongoing management [12][13]. - The high cost of mAbs, often thousands of yuan per injection, poses a barrier to access, and their effectiveness can vary among patients [13].

经过20 多年的发展，公司已经将人口过亿、GDP 排名前三十的新兴市场国家全部覆盖。2024 年位于济 南的白蛋白紫杉醇生产线获得了欧洲药品管理局GMP 证书、欧盟委员会上市批准，并于次月开始在欧 盟、英国法规市场销售。截止至2024 年底，公司引进了16 款产品，已在 60 余个国家提交了 120 多项注 册申请；白蛋白紫杉醇、英夫利西单抗、贝伐珠单抗、利拉鲁肽等产品2025 年将陆续在多个国家、地 区获批注册，实现上市销售。我们认为，随着白蛋白紫杉醇开始销售，以及2025 年更多产品在海外注 册/销售，公司海外市场销售值得期待。 创新药平台重估：截止至2024 年底，公司已经构建了领先的重组蛋白药物、抗体药物、递送系统技 术、微生态制剂研发及产业化、载体疫苗等五大技术平台，已经成功研发2 个III 期临床资产、2 个早期 临床资产。其中，人干扰素α1b 吸入溶液国内处于III 期，同时取得了美国临床许可；聚乙二醇化人粒 细胞刺激因子注射液处于III 期；GB18中国药监局已受理IND 申请 ，美国处于Pre-IND 阶段。 投资建议 我们认为，公司2024 年已经实现扭亏为盈，海外商业化处于快速兑现阶段， ...

[Table_StockNameRptType] 科兴制药（688136） 公司点评 新兴市场出海策略收获，一季度海外增利显著 -50% 0% 50% 100% 150% 200% 科兴制药 沪深300 分析师：谭国超 执业证书号：S0010521120002 邮箱：tangc@hazq.com 联系人：任婉莹 执业证书号：S0010123060034 邮箱：renwanying@hazq.com [相关报告 Table_CompanyReport] 1.【华安医药】科兴制药（688136.SH） 公司深度：重组蛋白业务稳健增长，出 口海外未来可期 2023-12-06 2.【华安医药】公司点评科兴制药 （688136.SH）：24Q1 扭亏为盈，海 外重组蛋白业务即将收获 2024-4-30 | | | | 报告日期： | 2025-04-28 | | | --- | --- | --- | | [Table_BaseData] 收盘价（元） | | 38.23 | | 近 12 个月最高/最低（元） | 42.10/13.67 | | | 总股本（百万股） | | 200 | | 流通股本（百万股） | ...